SarcopeniaPhase 1NCT01818609
Study of Inactivity on Metabolism of Elderly Muscles
A Phase 1 study testing Step reduction in people with Sarcopenia, run by McMaster University at 1 site in Canada.
Trial summary
Skeletal muscle mass declines with inactivity (casting is a good example) and increases with activity (such as weightlifting). Whether muscle mass increases or decreases, is determined by whether more new proteins within muscle are made than are broken down. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Step reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2011to Dec 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female
- Aged 60 to 80 years old
- Non-smoker Generally healthy and can tolerate the resistance exercise and protein drink
Who cannot join
- Allergies to whey protein
- Health problems such as: heart disease, rheumatoid arthritis of the knee joint, diabetes, poor lung function, uncontrolled hypertension, or any health conditions that might put participants at risks for this study
- Failed an exercise stress test
- Taking metformin and/or other medications for the control of blood glucose even though one might not be classified as diabetic
- Taking prescribed blood thinners such as warfarin and heparin but excluding aspirin
- Taking medications for lung and kidney conditions but excluding medication for asthma that is under control
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Reduce Daily Step Count on Muscle Protein Metabolism in Older Persons
Skeletal muscle mass declines with inactivity (casting is a good example) and increases with activity (such as weightlifting). Whether muscle mass increases or decreases, is determined by whether more new proteins within muscle are made than are broken down. The investigators know that feeding protein increases the synthesis of new proteins but that the response of older muscles to protein feeding is blunted compared with the young. This resistance of the elderly to muscle building stimuli may be the primary reason that muscle mass is lost in aging. The investigators also know that periods of muscle disuse such as casting result in a person's muscle shrinking due, the investigators believe, to a lower rate of synthesis of new muscle proteins. Age-related muscle loss begins around 50 years old and proceeds at approximately 1% for every year after. Elderly persons would likely fare well with advancing age if their muscle loss were simply linear; however, a rate of muscle loss of 1% annually is a 'population view' and does not represent what occurs during short periods of muscle disuse (i.e. during hospitalization or illness), which occur with increasing frequency in elderly persons. During periods of disuse, the resistance of elderly muscles to protein nutrition may be worsened. The investigators will measure how quickly new proteins are made at rest and after protein feeding in elderly men, before and after a 14 day period of reduced activity brought on by having people reduce their daily step count.
- Conditions
- Sarcopenia
- Being tested
- Step reduction
- Keywords
- sarcopenia, muscle, reduced activity, insulin sensitivity, protein, step reduction, muscle protein synthesis, whey protein, leg strength, whole body protein
- Medical subject headings
- Sarcopenia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Step reductionBehavioural
Also called Sedentary behaviour
taking less than 1500 steps/d
| Study group | Role | What they receive |
|---|---|---|
| Step Reduction | Experimental | Step reduction:
* Take less than 1500 steps/d
* No disease Receives: Behavioral: Step reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional synthetic rate (FSR) of myofibrillar muscle protein
rate of making new muscle proteins
Measured: over 5h
Secondary outcomes (3)
Blood amino acid concentrations
concentration of amino acids in blood
Measured: over 5h
Intramuscular signalling protein status
phosphorylation of key signalling proteins
Measured: over 5h
Insulin sensitivity via blood sampling
measure of insulin concentration
Measured: over 5h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2013 (estimated)
- Study startSep 2011
- Primary completionSep 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stuart M Phillips, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01818609
- Sponsor's protocol ID
- 267
- Status last verified
- Mar 2013
- First submitted
- 19 Jul 2011
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Reduce Daily Step Count on Muscle Protein Metabolism in Older Persons
- ClinicalTrials.gov ID
- NCT01818609
- Acronym / sponsor ID
- 267
- Conditions
- Sarcopenia
- Keywords
- sarcopenia, muscle, reduced activity, insulin sensitivity, protein, step reduction, muscle protein synthesis, whey protein
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 26 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Skeletal muscle mass declines with inactivity (casting is a good example) and increases with activity (such as weightlifting). Whether muscle mass increases or decreases, is determined by whether more new proteins within muscle are made than are broken down. The investigators know that feeding protein increases the synthesis of new proteins but that the response of older muscles to protein feeding is blunted compared with the young. This resistance of the elderly to muscle building stimuli may be the primary reason that muscle mass is lost in aging. The investigators also know that periods of muscle disuse such as casting result in a person's muscle shrinking due, the investigators believe, to a lower rate of synthesis of new muscle proteins. Age-related muscle loss begins around 50 years old and proceeds at approximately 1% for every year after. Elderly persons would likely fare well with advancing age if their muscle loss were simply linear; however, a rate of muscle loss of 1% annually is a 'population view' and does not represent what occurs during short periods of muscle disuse (i.e. during hospitalization or illness), which occur with increasing frequency in elderly persons. During periods of disuse, the resistance of elderly muscles to protein nutrition may be worsened. The investigators will measure how quickly new proteins are made at rest and after protein feeding in elderly men, before and after a 14 day period of reduced activity brought on by having people reduce their daily step count.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Step Reduction | Experimental | Behavioral: Step reductionStep reduction: * Take less than 1500 steps/d * No disease |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or Female
- Aged 60 to 80 years old
- Non-smoker Generally healthy and can tolerate the resistance exercise and protein drink
Key exclusion criteria (6 listed)
- Allergies to whey protein
- Health problems such as: heart disease, rheumatoid arthritis of the knee joint, diabetes, poor lung function, uncontrolled hypertension, or any health conditions that might put participants at risks for this study
- Failed an exercise stress test
- Taking metformin and/or other medications for the control of blood glucose even though one might not be classified as diabetic
- Taking prescribed blood thinners such as warfarin and heparin but excluding aspirin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Step reductionAlso: Sedentary behaviourtaking less than 1500 steps/d | Behavioural | Step Reduction |
Primary outcome
Fractional synthetic rate (FSR) of myofibrillar muscle protein
Time frame: over 5h
rate of making new muscle proteins
3 secondary outcomes
Blood amino acid concentrations
Time frame: over 5h
Intramuscular signalling protein status
Time frame: over 5h
Insulin sensitivity via blood sampling
Time frame: over 5h
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart M Phillips, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Step reduction in people with Sarcopenia, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fractional synthetic rate (FSR) of myofibrillar muscle protein (time frame: over 5h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020.